Cognitive Behavioral Therapy for Treating Recently Abused Women With Post-Traumatic Stress Disorder

This study has been completed.
Sponsor:
Collaborators:
Summa Health System
Butler Hospital
Information provided by (Responsible Party):
The University of Akron
ClinicalTrials.gov Identifier:
NCT00602069
First received: January 18, 2008
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

This study will evaluate the effectiveness of a brief cognitive behavioral treatment, Helping to Overcome PTSD through Empowerment, in treating abused women with post-traumatic stress disorder who are living in shelters.


Condition Intervention Phase
Post-Traumatic Stress Disorder
Battered Women
Behavioral: Helping to Overcome PTSD through Empowerment (HOPE)
Behavioral: Treatment as usual
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of PTSD in Recently Battered Women Living in Shelters

Resource links provided by NLM:


Further study details as provided by The University of Akron:

Primary Outcome Measures:
  • PTSD symptom severity [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effective use of resources [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Resource loss [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Social functioning [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: No ]
  • Revictimization [ Time Frame: Measured at Month 8 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: May 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive cognitive behavioral therapy through the Helping to Overcome PTSD through Empowerment program
Behavioral: Helping to Overcome PTSD through Empowerment (HOPE)
HOPE includes a maximum of 16 sessions of cognitive behavioral therapy. The sessions will emphasize stabilization and empowerment, both of which are identified as important goals by the theoretical and empirical literature on abused women and PTSD.
Other Name: HOPE
Active Comparator: 2
Participants will receive standard shelter services
Behavioral: Treatment as usual
Treatment as usual includes standard shelter services for abused women.

Detailed Description:

Intimate partner violence is a serious social problem with potentially severe mental health and functional consequences consistent with post-traumatic stress disorder (PTSD). Shelters provide an important resource for abused women in that they offer emergency shelter, support, and access to community resources that can aid in establishing long-term safety for women and their children. However, recent research suggests that symptoms of PTSD can compromise abused women's ability to access and effectively use these resources, emphasizing the importance of initiating treatment for PTSD. Despite the fact that on an annual basis 300,000 battered women and children access shelter services, virtually no research has investigated treatment of PTSD in sheltered abused women. A woman's entry into a shelter seems to be a prime time to begin any necessary psychological treatment. Helping to Overcome PTSD through Empowerment (HOPE), a brief cognitive behavioral treatment that emphasizes stabilization and empowerment of women, may help in treating abused women with PTSD. This study will evaluate the effectiveness of HOPE in treating abused women with PTSD who are in shelters.

Participation in this single-blind study will begin during a woman's shelter stay and will end 8 months after she completes the shelter treatment period. All potential participants will first undergo an initial interview, which will include questions about their abusive relationships, emotional difficulties, stressful events, and other previous treatments. Participants invited to continue with the study will be randomly assigned to the HOPE program or to shelter treatment as usual. Participants assigned to the HOPE program will participate in a maximum of 16 counseling sessions, with up to 10 of these sessions taking place while they are at the shelter. During these sessions, participants will learn skills to help manage emotional difficulties and ways to deal with their abusive relationships. Participants will attend two 60- to 90-minute sessions each week until they complete of the 10 shelter-based counseling sessions or depart from the shelter. Counseling sessions will continue at St. Thomas Hospital or other agreed-upon location twice per week during the first 8 weeks after departure from the shelter. All participants will repeat the initial interview and/or questionnaire at various times during and after the shelter stay, for a total of eight assessments. The final interview assessment will occur 6 months after participants complete the counseling sessions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for PTSD or subthreshold PTSD
  • Resident of a battered women's shelter
  • Abused in the month prior to study entry

Exclusion Criteria:

  • Significant suicidal ideation or risk
  • Current psychotic symptoms
  • Current alcohol or drug dependence
  • Lifetime history of bipolar disorder
  • Concurrent psychosocial treatment
  • Any change in medication in the month prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602069

Locations
United States, Ohio
University of Akron
Akron, Ohio, United States, 44325
Sponsors and Collaborators
The University of Akron
Summa Health System
Butler Hospital
Investigators
Principal Investigator: Dawn M. Johnson, PhD Summa Health System
  More Information

Publications:
Responsible Party: The University of Akron
ClinicalTrials.gov Identifier: NCT00602069     History of Changes
Other Study ID Numbers: R34 MH080786, R34MH080786, DATR AD-TS
Study First Received: January 18, 2008
Last Updated: June 21, 2013
Health Authority: United States: Federal Government

Keywords provided by The University of Akron:
PTSD
Intimate Partner Violence
Cognitive Behavioral Therapy
Empowerment

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014